FDA Adverse Event Death Summary report: N

HEPARIN LOCK FLUSH SYRINGES

MDR report key: 7596044 · Received June 12, 2018

Report

Report Number
MW5077796
Event Type
Death
Date Received
June 12, 2018
Date of Event
March 6, 2018
Report Date
June 11, 2018
Manufacturer
BD MEDICAL / BECTON DICKINSON AND COMPANY
Product Code
NZW
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

AFTER SHE USED HEPARIN LOCK FLUSH ON (B)(6) 2018, SHE GOT SYMPTOMS LIKE DIARRHEA, CONSTIPATION AND NAUSEA BUT ON (B)(6) 2018 THE SYMPTOMS INCREASED. THE DR ATTENDED SENT HER TO (B)(6) EMERGENCY, THEY SAID SHE HAD BLOOD INFECTIONS AND THEY GAVE HER ANTIBIOTICS. LATER THEY SAID HER SITUATION WAS UNUSUAL, HER URINE ANALYSIS CONTAINED BACTERIA. SHE DIED AS A RESULT OF USING HEPARIN LOCK FLUSH. IT CONTAINED BACTERIA. THE MFR COMPANY RECALLS THIS MEDICATION FOR THIS REASON. STRENGTH: 500USP UNITS / 5ML (100USP/ML MILLILITRE(S)). "DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: NO." QUANTITY: 30 INJECTIONS, FREQUENCY: TWICE A DAY. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2018, DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2018; FOR LINE CARE DAILY FLUSH EACH LUMEN DAILY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
436991 HEPARIN LOCK FLUSH SYRINGES HEPARIN LOCK FLUSH SYRINGES NZW BD MEDICAL / BECTON DICKINSON AND COMPANY 726111N

Patients

Seq Age Sex Outcome Treatment
1 20 YR Death